The Use of Nutropin Depot in HIV-infected Adult Males

• Status: Withdrawn
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 with lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is to determine the effect of GH depot on body weight and lean tissue mass (LTM).

The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2) gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such as glucose intolerance and edema, will be monitored at every visit.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Genentech, Inc.

Criteria

Inclusion Criteria:

• adult males ≥ 18 years of age

• mild to moderate lipoatrophy

• stable protease inhibitor therapy for at least six months.

Exclusion Criteria:

• Con-current supra-infection with acute illness defined by fever or bacterial culture

• malignancy

• females

• diabetes mellitus

• CNS tumors.